Online Course

Invitation to register for the CDSA online course: Current regulatory requirements for conducting clinical trials in India for investigational new drugs/new drug (Version 3.0) – Online registration link is now open

Dear Sir/Madam,

Welcome to the Joy of Learning!

Clinical Development Services Agency (CDSA) is pleased to announce our online course on “Current regulatory requirements for conducting clinical trials in India for investigational new drugs/new drug (Version 3.0)”.

This course is developed by the Clinical Development Services Agency (CDSA) in partnership with the Central Drugs Standard Control Organisation (CDSCO). CDSA is an extramural unit of the Translational Health Science and Technology Institute (THSTI). THSTI is an autonomous organisation of the Department of Biotechnology, Ministry of Science & Technology, Government of India. CDSCO is the National Regulatory Authority (NRA) of India. It is under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. This course is developed with the National Programme on Technology Enhanced Learning (NPTEL).

COURSE OBJECTIVES AND EXPECTED LEARNING OUTCOME 

  • Current New Drugs and Clinical Trials Rules 2019 for conducting clinical trials of the new drug or investigational new drug (IND) to be manufactured or imported in India
  • Essential documents required for the conduct and approval of clinical trials, new drug/IND  
  • Essence and purpose of important trial-related guidelines, such as Good Clinical Practice (GCP), national ethical guidelines for biomedical & health research for human participants (2017), etc

We invite you to join the course by clicking the below link (all the details about the course can be accessed from the link):

https://onlinecourses.nptel.ac.in/noc21_ge14/preview

This course is free to enroll. The last date to register is February 15, 2021. The courses begin on  February 15, 2021 .

Course duration : 8 weeks 

The course is hosted on SWAYAM and accessed by anyone, anywhere at any time. The mode of course delivery is –

        • Video lecture
        • specially prepared reading material that can be downloaded/printed
        • self-assessment tests through tests and quizzes and
        • an online discussion forum for clearing the doubts.

We request you to kindly circulate this information among your friends and colleagues and request them to register. If you need any assistance, please contact us. We will be happy to help you. 

We wish you happy learning.

 

Thanks and Best Regards,

प्रशिक्षण विभाग/Training Department
क्लिनिकल डेवलोपमेंट सर्विसेस एजेंसी
Clinical Development Services Agency
(टी. एच. एस. टी. आई.  की एक बाह्य इकाई, भारत सरकार के विज्ञान और प्रौद्योगिकी मंत्रालय के जैव-प्रौद्योगिकी विभाग का एक स्वायत्त संस्थान)
(An extramural unit of Translational Health Science & Technology Institute, Dept of Biotechnology, Ministry of Science & Technology, Govt. of India)
NCR Biotech Science Cluster
3rd Milestone, Gurgaon- Faridabad Expressway, Faridabad 121001
Tel: +91-129 287 6468
Email: training.cdsa@thsti.res.in